eligibility_summary
Adults 18–69 with histologically/cytologically confirmed locally advanced/metastatic solid tumors, failed/intolerant/no effective standard therapy, ROR1+ by central IHC, adequate organ/marrow, ≥1 RECIST v1.1 measurable lesion, ECOG 0–1, survival ≥3 mo, consent. Exclude: prior anti‑ROR1, therapy within 4 wks, active CNS mets, serious CV disease, uncontrolled effusions, HIV+, active HBV/HCV/TB, pregnant/lactating, likely noncompliance or investigator‑judged risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: RD14-01, an autologous ROR1-targeted CAR T-cell therapy (adoptive cellular immunotherapy). Patients receive lymphodepleting therapy followed by IV infusion of engineered T cells expressing a CAR against ROR1. Mechanism of action: CAR binding to ROR1 on tumor cells triggers T-cell activation (via CD3ζ and co-stimulatory domains), proliferation, cytokine release, and cytotoxic killing independent of native TCR recognition. Targets: ROR1-positive tumor cells, ROR1 is a receptor tyrosine kinase-like orphan receptor involved in non-canonical Wnt (Wnt5a/ROR1) signaling that supports tumor survival, migration, and metastasis. Pathways/cells affected: tumor ROR1/Wnt signaling, effector CD8+/CD4+ CAR T lymphocytes executing immune-mediated tumor cell lysis. Phase: single-arm, open-label Phase 1/2 in ROR1+ advanced solid tumors.